Sodium diclofenac, a Non Steroid Anti Inflammatory Drug (NSAID), has irritating stomach side effect and the use of alginate capsule shells in preparing a sodium diclofenac capsule can reduce the side effect of natrium diclofenac. The objectives of this research were to evaluate the effect of PEG 6000 addition to the capsule shells towards sodium diclofenac release from the alginate capsules shells and to evaluate the physical properties of alginate capsule shells such as the water content equilibrium and the brittleness of the alginate capsule shells.
Alginate capsule shells were made from alginate 80 - 120 cP with and without the addition of PEG 6000. The study of alginate capsule shells physical properties included the evaluation of water vapor content equilibrium and brittleness towards relative humidity (RH). Physical properties evaluation was done by storing capsule shells in climatic chamber at 25ºC with relative humidity (RH) 30, 45, 50, 60, 75, and 90% for 3 days so the capsule shells could adsorp or desorp water vapor. Then the stored capsule shells was evaluated their brittleness and water vapor content. Then the dissolution test was done using paddle apparatus dissolution tester in acid stage and buffer stage medium, then the sodium diclofenac concentration was measured using UV spectrophotometer.
Results showed that alginate capsule shells that was added PEG 6000 was less brittle than the capsule shells without PEG 6000. This could be seen on storage at relative humidity (RH) 50%, the brittleness of alginate capsule shells without PEG 6000 was 50% and the water vapor content was 14.12% while the alginate capsule shells with PEG 6000 was 33.34% and the water vapor content was 17.41%. PEG 6000 addition in alginate capsule shells formulation increased dissolution of sodium diclofenac from alginate capsule shells. This could be known from dissolution result at 165 minute, sodium diclofenac release from alginate capsule shells without PEG 6000 was 54.54%. While alginate capsule shells with PEG 6000 was 83.71%. From this research, can be concluded that alginate capsule shells that is formulated with PEG 6000 meets the USP XXXII requirement.